Clinical trial Recruiting at 1 site Interventional Ages 6 to 12

Using clear aligners to expand the upper dental arch in children with cleft lip and palate

Official title: Evaluation of Maxillary Expansion Using Clear Aligners' Therapy in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Pilot Study

Run by Cairo University · NCT06994754 · Data updated 2026-11-12

This study is testing if clear aligners can help expand the upper jaw in children aged 6-8 with cleft lip and palate.

More Cleft Lip and Palate trials

Quick facts

Study typeInterventional
Ages6 Years to 12 Years
SexAll
Enrollment10 (estimated)
SponsorCairo University
Academic / other
Locations1 site (Cairo, Select)
StatusRecruiting
StartedApril 6, 2025
Main results expectedOctober 2026
Study endsDecember 2026
Registry record updatedJune 12, 2025
Trial IDNCT06994754 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 6-8 years with bilateral cleft lip and palate who have not undergone previous orthodontic treatment.

Probably not a fit

Patients with syndromic cleft lip and palate or those taking medications that influence growth may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of clear aligners in expanding the upper dental arch of children aged 6-8 years with cleft lip and palate. Participants will wear a series of aligners, each for 10 days, and attend monthly check-ups to monitor progress. The study aims to determine if these aligners can achieve significant changes in the dental and skeletal structure of the maxilla. After completing the aligner treatment, 3D x-rays and intraoral scans will be conducted to assess the outcomes of the intervention.

Why it matters

Potential benefit: If successful, this approach could improve dental arch morphology and facilitate better surgical outcomes for children with cleft lip and palate.

How similar studies have gone: While the use of clear aligners for orthodontic treatment is well-established, this specific application for maxillary expansion in cleft lip and palate patients is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Mixed dentition.
* Both males and females.
* Bilateral cleft lip and palate.
* Lip repair performed between 3 and 6 months of age and palate repair performed between 12and 24 months of age.
* Presence of maxillary constriction that needs maxillary expansion.
* Good periodontal health.
* No previous orthodontic treatment.

Exclusion Criteria:

* Syndromic cleft lip and palate patients.
* Taking medications that influence growth.

Where it's running

  • Faculty of Dentistry - Cairo University
    Cairo, Select, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.